CA2684539A1 - Use of a composition comprising formoterol and beclometasone dipropionate for the prevention and/or treatment of an exacerbation of asthma - Google Patents

Use of a composition comprising formoterol and beclometasone dipropionate for the prevention and/or treatment of an exacerbation of asthma Download PDF

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Publication number
CA2684539A1
CA2684539A1 CA002684539A CA2684539A CA2684539A1 CA 2684539 A1 CA2684539 A1 CA 2684539A1 CA 002684539 A CA002684539 A CA 002684539A CA 2684539 A CA2684539 A CA 2684539A CA 2684539 A1 CA2684539 A1 CA 2684539A1
Authority
CA
Canada
Prior art keywords
use according
formoterol
combination
microgram
beclometasone dipropionate
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA002684539A
Other languages
French (fr)
Inventor
Paolo Chiesi
Ivano Rondelli
Daniela Acerbi
Gianluigi Poli
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Chiesi Farmaceutici SpA
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=38458097&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2684539(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Individual filed Critical Individual
Publication of CA2684539A1 publication Critical patent/CA2684539A1/en
Abandoned legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/008Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pain & Pain Management (AREA)
  • Otolaryngology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

The present invention relates to the use of a composition comprising a fixed combination of a) formoterol, a pharmaceutically acceptable salt or solvate thereof or a solvate of such a salt; and b) beclometasone dipropionate; for the manufacture of a medicament for use in the prevention and/or treatment of an exacerbation of asthma, intermittent asthma and/or episodes in chronic asthma during the maintenance therapy of asthma with the same composition for symptomatic relief, when needed.

Claims (27)

1. Use of a composition comprising a fixed combination of a) formoterol, a pharmaceutically acceptable salt or solvate thereof or a solvate of such a salt; and b) beclometasone dipropionate;

for the manufacture of a medicament for use in the prevention and/or treatment of an exacerbation of asthma, intermittent asthma and/or episodes in chronic asthma during the maintenance therapy of asthma with the same composition for symptomatic relief, when needed.
2. Use according to claim 1, wherein the molar ratio of (a) to (b), calculated as formoterol to beclometasone dipropionate, is from 1:1 to 1:500.
3. Use according to claim 2, wherein the molar ratio of (a) to (b), calculated as formoterol to beclometasone dipropionate, is from 1:1 to 1:100.
4. Use according to claim 3, wherein the molar ratio of (a) to (b), calculated as formoterol to beclometasone dipropionate, is from 1:3 to 1:30.
5. Use according to claim 4, wherein the molar ratio of (a) to (b), calculated as formoterol to beclometasone dipropionate, is 1:12.8.
6. Use according to claim 4, wherein the molar ratio of (a) to (b), calculated as formoterol to beclometasone dipropionate, is 1:25.6.
7. Use according to any one of claims 1 to 6 wherein the first active ingredient is formoterol fumarate dihydrate.
8. Use according to any one of claims 1 to 6 wherein the first active ingredient is the R,R-enantiomer of formoterol or pharmaceutically acceptable salt or solvate thereof or a solvate of such a salt.
9. Use according to any previous claim wherein the daily dose of formoterol for adults, including maintenance therapy, may be as high as 168 microgram, preferably 100 microgram, and more preferably 84 microgram and even more preferably 72 microgram.
10. Use according to any previous claim wherein the daily dose of beclometasone dipropionate for adults, including maintenance therapy, may be as high as 5600, preferably 2800 microgram, more preferably 2400 microgram, even more preferably 1400 and most preferably 1200 microgram.
11. Use according to any previous claim, wherein the composition is administered by inhalation orally or intranasally.
12. Use according to claim 11, wherein the combination is administered by a dry powder inhaler, a pressurized metered dose inhaler, or a nebuliser.
13. Use according to claim 12, wherein the combination is formulated in form of a dry powder composition and may comprise one or more suitable diluents or carriers such as lactose, dextran, mannitol or glucose and preferably alpha-lactose monohydrate.
14. Use according to claim 13, wherein both the active ingredients (a) and (b) of the combination and the diluent/carrier may be in a micronized form.
15. Use according to claim 14, wherein a coarse diluent/carrier may be added to the composition to form an ordered mixture
16. Use according to claim 15, wherein said ordered mixture may optionally contain an additive to promote the release of the active ingredients selected from substances with anti-adherent, glidant or lubricant properties such as magnesium stearate.
17. Use according to claim 12, wherein the combination is formulated in the form of a pressurized metered dose inhaler and wherein both the active ingredients (a) and (b) in micronized form are suspended in a liquid propellant mixture.
18. Use according to claim 12, wherein the combination is formulated in the form of a pressurized metered dose inhaler and wherein one of the two active ingredient is suspended and the other is completely dissolved in a liquid propellant mixture.
19. Use according to claim 12, wherein the combination is formulated in the form of a pressurized metered dose inhaler wherein both the active ingredients (a) and (b) are completely dissolved in a liquid propellant mixture.
20. Use according to claim 19, wherein the liquid propellant mixture comprises HFA 134a (1,1,1,2-tetrafluoroethane), HFA 227 (1,1,1,2,3,3,3-heptafluoropropane) or their mixtures, optionally in combination with one or more cosolvent, surfactant, lubricant, antioxidant, stabilizing and or preserving agent.
21. Use according to claim 20, wherein the liquid propellant mixture comprises HFA 134a (1,1,1,2-tetrafluoroethane), ethanol as a cosolvent and an aqueous mineral acid as stabilising agent.
22. Use according to claim 21, wherein the aqueous mineral acid is 1M
hydrochloric acid.
23. Use according to any one of claims 19 to 22 which upon actuation of the pressurized metered dose inhaler, on evaporation of the propellant mixture, feature an average particle size of the two active ingredients equal or below 1.1 micrometer.
24. Use according to claim 12, wherein the combination is formulated in the form of a nebulizer either as a unit dose or multidose formulation.
25. Use according to claim 24, wherein both the active ingredients (a) and (b), in micronized form are suspended to give a nebulized aqueous or hydroalcoholic suspension with or without suitable pH or tonicity adjustment and optional addition of stabilizing and or preserving agent.
26. Use according to claim 25, wherein both the active ingredients (a) and (b) are dissolved to give a nebulized aqueous or hydroalcoholic solution with or without suitable pH or tonicity adjustment and optional addition of stabilizing and or preserving agent.
27. Use according to claim 24, wherein one of the two active ingredient is suspended and the other is completely dissolved to give a nebulized aqueous or hydroalcoholic suspension with or without suitable pH or tonicity adjustment and optional addition of stabilizing and or preserving agent.
CA002684539A 2007-04-19 2008-04-16 Use of a composition comprising formoterol and beclometasone dipropionate for the prevention and/or treatment of an exacerbation of asthma Abandoned CA2684539A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP07007930.6 2007-04-19
EP07007930A EP1982709A1 (en) 2007-04-19 2007-04-19 Use of a composition comprising formoterol and beclomethasone dipropionate for the prevention or treatment of an acute condition of asthma
PCT/EP2008/003012 WO2008128685A1 (en) 2007-04-19 2008-04-16 Use of a composition comprising formoterol and beclometasone dipropionate for the prevention and/or treatment of an exacerbation of asthma

Publications (1)

Publication Number Publication Date
CA2684539A1 true CA2684539A1 (en) 2008-10-30

Family

ID=38458097

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002684539A Abandoned CA2684539A1 (en) 2007-04-19 2008-04-16 Use of a composition comprising formoterol and beclometasone dipropionate for the prevention and/or treatment of an exacerbation of asthma

Country Status (30)

Country Link
US (1) US20080261932A1 (en)
EP (3) EP1982709A1 (en)
JP (2) JP5492072B2 (en)
KR (3) KR101668203B1 (en)
CN (1) CN101657191B (en)
AU (1) AU2008241045C1 (en)
BR (1) BRPI0809800A2 (en)
CA (1) CA2684539A1 (en)
CO (1) CO6220945A2 (en)
CY (1) CY1117568T1 (en)
DK (1) DK2146704T3 (en)
EA (1) EA018589B1 (en)
ES (2) ES2740103T3 (en)
GE (1) GEP20145999B (en)
HK (1) HK1137357A1 (en)
HR (1) HRP20160588T1 (en)
HU (1) HUE029263T2 (en)
IL (1) IL201632A (en)
MA (1) MA31315B1 (en)
ME (1) ME00945B (en)
MX (1) MX2009010851A (en)
MY (1) MY169579A (en)
NZ (1) NZ580526A (en)
PL (2) PL2146704T3 (en)
RS (1) RS54874B1 (en)
SI (1) SI2146704T1 (en)
TN (1) TN2009000390A1 (en)
TR (1) TR201909857T4 (en)
UA (1) UA100237C2 (en)
WO (1) WO2008128685A1 (en)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1982709A1 (en) 2007-04-19 2008-10-22 CHIESI FARMACEUTICI S.p.A. Use of a composition comprising formoterol and beclomethasone dipropionate for the prevention or treatment of an acute condition of asthma
DK2482799T3 (en) * 2009-10-02 2014-09-01 Chiesi Farma Spa PHARMACEUTICAL AEROSOL FORMULATIONS OF FORMOTEROL AND BECLOMETASONDIPROPIONATE
CN102247597B (en) * 2010-05-19 2015-01-07 天津金耀集团有限公司 Novel inhalant containing glucocorticoid and bronchodilator
ES2938466T3 (en) * 2012-01-25 2023-04-11 Chiesi Farm Spa Dry powder formulation comprising a corticosteroid and a beta-adrenergic agent for administration by inhalation
US11052202B2 (en) * 2012-11-07 2021-07-06 Chiesi Farmaceutici S.P.A. Drug delivery device for the treatment of patients with respiratory diseases
WO2018051131A1 (en) * 2016-09-19 2018-03-22 Mexichem Fluor S.A. De C.V. Pharmaceutical composition
CN107233311B (en) * 2017-06-27 2020-12-04 长风药业股份有限公司 Atomizing agent with arformoterol and glycopyrronium bromide as active ingredients and preparation method thereof
WO2024097413A1 (en) * 2022-11-03 2024-05-10 Dana-Farber Cancer Institute, Inc. Methods of treating anemia using formoterol or a pharmaceutically acceptable salt thereof

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5795564A (en) * 1991-04-05 1998-08-18 Sepracor, Inc. Methods and compositions for treating pulmonary disorders using optically pure (R,R)-formoterol
DE69232462T2 (en) 1991-12-18 2002-10-10 Astrazeneca Ab COMPOSITION CONTAINING FORMOTEROL AND BUDESONIDE
SE9802073D0 (en) * 1998-06-11 1998-06-11 Astra Ab New use
ME00220B (en) 2000-05-22 2010-10-10 Chiesi Farm Spa Stable pharmaceutical solution formulations for pressurised metered dose inhalers
FI20002177A0 (en) * 2000-10-02 2000-10-02 Orion Yhtymae Oyj New combination for asthma therapy
FI20002216A0 (en) * 2000-10-06 2000-10-06 Orion Yhtymae Oyj Combination particles for asthma therapy
FI20002215A0 (en) * 2000-10-06 2000-10-06 Orion Yhtymae Oyj Combination Particles
ATE465712T1 (en) 2002-03-01 2010-05-15 Chiesi Farma Spa ULTRAFINE COMPOSITIONS OF FORMOTEROL
EP1982709A1 (en) 2007-04-19 2008-10-22 CHIESI FARMACEUTICI S.p.A. Use of a composition comprising formoterol and beclomethasone dipropionate for the prevention or treatment of an acute condition of asthma

Also Published As

Publication number Publication date
MA31315B1 (en) 2010-04-01
KR20100014408A (en) 2010-02-10
MY169579A (en) 2019-04-22
EP2146704A1 (en) 2010-01-27
HUE029263T2 (en) 2017-02-28
HK1137357A1 (en) 2010-07-30
AU2008241045A1 (en) 2008-10-30
ES2740103T3 (en) 2020-02-05
WO2008128685A1 (en) 2008-10-30
PL2146704T3 (en) 2016-09-30
IL201632A (en) 2016-09-29
DK2146704T3 (en) 2016-05-23
JP2010524873A (en) 2010-07-22
CN101657191A (en) 2010-02-24
EA200901201A1 (en) 2010-04-30
KR20150038618A (en) 2015-04-08
MX2009010851A (en) 2009-11-05
ME00945B (en) 2012-06-20
UA100237C2 (en) 2012-12-10
CY1117568T1 (en) 2017-04-26
EP3034073B1 (en) 2019-06-12
AU2008241045B2 (en) 2013-06-20
US20080261932A1 (en) 2008-10-23
AU2008241045C1 (en) 2023-06-15
CN101657191B (en) 2014-06-11
GEP20145999B (en) 2014-01-10
HRP20160588T1 (en) 2016-07-01
KR20150082699A (en) 2015-07-15
IL201632A0 (en) 2010-05-31
EP1982709A1 (en) 2008-10-22
TR201909857T4 (en) 2019-07-22
KR101668203B1 (en) 2016-10-20
TN2009000390A1 (en) 2010-12-31
RS54874B1 (en) 2016-10-31
EP2146704B1 (en) 2016-03-23
CO6220945A2 (en) 2010-11-19
KR101621676B1 (en) 2016-05-16
PL3034073T3 (en) 2019-11-29
SI2146704T1 (en) 2016-05-31
JP2014005312A (en) 2014-01-16
NZ580526A (en) 2012-07-27
EP3034073A1 (en) 2016-06-22
ES2568497T3 (en) 2016-04-29
JP5492072B2 (en) 2014-05-14
EA018589B1 (en) 2013-09-30
BRPI0809800A2 (en) 2014-10-07

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Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20130404

FZDE Discontinued

Effective date: 20160525